Regulatory Specialist
4 months ago
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
We are a company inspiring the extraordinary, For more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives.
The role is opened to continue our daily milestone in serving our patients & partners and give them the highest level of support & partnership which is aligned with our daily mission to alleviate pain, restore health, and extend life.
In this vital role you will be responsible of setting submission plan for EU MDR changes, driving accountability and operational excellence for execution in compliance with Medtronic standards and national regulatory requirements for Egypt & Libya. You will develop and maintain a broad set of collaborative relationships across the organization and with external stakeholders and partners that will allow you to successfully contribute to achieving organizational goals.
Responsibilities may include the following and other duties may be assigned:
- Directs or performs planning, coordination, and preparation of EUMDR documents for regulatory submissions.
- Dossier review and submission responsibilities for EUMDR changes.
- Promote, maintain, and improve compliance with country regulatory requirements.
- Ensure alignment of regulatory objectives with regional/ global regulatory objectives and commercial plans.
- Monitors and improves tracking / control systems.
Required Knowledge and Experience:
- Bachelor’s degree, Pharmaceutical/Medical/ Science background.
- Minimum 1-2 years of related regulatory experience.
- Experience with Egypt Medical Devices regulatory requirements.
- Organizational skills & regulatory project management skills.
- Strong communication skills both verbal and written.
- Self-motivated, proactive, dynamic, organized, and decisive.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
here
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